This is a single dose study in healthy male and female (of non-child bearing potential) volunteers, to assess the safety, effects on the body, and blood and urine drug levels of AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
72
Research Site
Baltimore, Maryland, United States
Adverse event monitoring.
Time frame: From baseline up to 10 days.
Assessment of vital signs and physical examination.
The vital signs of body temperature, blood pressure and pulse are going to be measured.
Time frame: From baseline up to 10 days.
Clinical laboratory tests: hematology.
Time frame: From baseline up to 10 days.
Clinical laboratory tests: urine analysis.
Time frame: From baseline up to 10 days.
Evaluation of 12-lead digital electrocardiogram (ECG).
QT/QTc interval, rhythm, rate, morphology is going to be measured.
Time frame: From baseline up to 10 days.
Assessment of telemetry.
As reported by investigator.
Time frame: From baseline up to 10 days.
Columbia-Suicide Severity Rating Scale (C-SSRS)
Columbia-Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Time frame: From baseline up to 10 days.
Pharmacokinetics (PK) in the terms of AUC, AUC(0-t), AUC(0-24).
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Where (AUC(0-t)) is area under the plasma concentration-time curve from zero to the last measurable concentration and (AUC(0-24)) area under the plasma concentration-time curve from zero to 24 hours post-dose.
Time frame: Up 4 days
Investigation on the effect of AZD3293 on biomarkers relevant for Pharmacodynamics in plasma.
Biomarker PD Aβ (1-40, 1-42) parameters are: * Maximum observed plasma concentration (Cmax) * Time to Cmax (tmax) * Minimum observed plasma concentration (Cmin) * Minimum observed plasma concentration below the individual healthy volunteer baseline (pre-dose biomarker concentration prior to dosing) (ΔCmin) * Time to Cmin (tmin) * Duration (T) of concentration below individual healthy volunteer baseline (BBL), if appropriate for the data (tBBL) * Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC(0-t)) * Area under the plasma concentration-time curve from zero to 24 hours post dose (AUC(0-24)) * Area under the plasma biomarker concentration curve from time zero to 24 hour that is below individual healthy volunteer baseline (ΔAUC(0-24)).
Time frame: Up to 4 days.
Investigation of the potential influence of food on Pharmacokinetics (PK) following a single dose of AZD3293.
Pharmacokinetics (PK) in the terms of plasma Cmax and AUC.
Time frame: Up to 4 days.
Investigation of the relationship between Pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD3293.
The Pharmacokinetics (PK) variables may be plasma concentrations or summary measurements such as Cmax or AUC. The Pharmacodynamics (PD) variables may include biomarkers in plasma such as Aβ (1-40, 1-42) or exploratory PD biomarkers, or safety variables.
Time frame: Up to 4 days.
Pharmacokinetics assessment in the terms of fu (%) (fraction of unbound AZD3293 and AZ13569724 in plasma).
Time frame: Up to 4 days.
Pharmacokinetics in the terms of Cmax (Maximum observed plasma concentration) and tmax (Time to Cmax ).
Time frame: Up to 4 days.